Developing allogeneic hMSC (human mesenchymal stem cells) or hMSC-based therapeutic products supported by sustainable scalable manufacturing takes years of time to develop and costs millions of dollars.
Successful development and commercialization of cell-based therapeutic product and process development not only requires a focus on quality to meet regulatory and manufacturing targets, but also needs scalability to meet clinically and commercially acceptable costs.
This webinar will explore the criticality of resource allocation during product and process development for moving novel cell-based therapeutics from product development to clinical implementation. There will also be discussion of the importance of considering long-term key raw material and scale-up needs early in development to enable early integration of products and processes, saving considerable time and money later on. Finally, the benefits of embedding a system with a demonstrated path to scalability will be examined.
Attendees will learn about: